In animal reproduction studies, increased fetal losses were observed in mice, rats, and rabbits and skull deformities were observed in rabbits with administration of mifepristone at doses lower than the human exposure level based on body surface area. These deformities were most likely due to the mechanical effects of uterine contractions resulting from inhibition of progesterone action. Birth defects have been reported with a continued pregnancy after a failed pregnancy termination with this drug in a regimen with misoprostol.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Termination of Pregnancy:
-Use is acceptable for the medical termination of intrauterine pregnancy through 63 or 70 days gestation.

For control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance:
-Use is contraindicated.

US FDA pregnancy category: X (Brand KORLYM)

Risk Summary: The risk of adverse developmental outcomes with a continued pregnancy after a failed pregnancy termination with this drug in a regimen with misoprostol is unknown; however, the process of a failed pregnancy termination could disrupt normal embryo-fetal development and result in adverse developmental effects.

Comments: Evaluate potential hazard to the fetus if this drug is used during pregnancy or pregnancy occurs while taking this drug.

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Limited data demonstrate undetectable to low levels of the drug in human milk with the relative (weight-adjusted) infant dose 0.5% or less as compared to maternal dosing. There is no information on the effects of this drug in a regimen with misoprostol in a breastfed infant or on milk production. The developmental and health benefits of breast-feeding should be considered along with any potential adverse effects on the breast-fed child from this drug in a regimen with misoprostol.

Termination of Pregnancy:
-Use should be avoided.

For control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance:
-A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references